GLUMA DESENSITIZER SINGLE DOSE 40X1 PCE 66001854Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI J014660018540), received between Mar 12, 2024 and Mar 12, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A DENTAL HYGIENE STUDENT HAD GLUMA DESENSITIZER APPLIED BY A FELLOW STUDENT WHILE IN CLASS. THE GLUMA WAS APPLIED WITHOUT A RUBBER DAM WHICH IS RECOMMENDED IN THE IFU. THE ONLY ISOLATION USED WAS COTTON ROLLS. THE GLUMA CAME IN CONTACT WITH HER GINGIVA ON TEETH # 24 & #25 CAUSING A CHEMICAL BURN, PAIN, SENSITIVITY, AND LOSS OF GINGIVA. SHE PREVIOUSLY HAD 2MM OF RECESSION ON THESE TEETH AND AFTER THE INCIDENT, # 25 NOW HAS 3MM OF RECESSION. SHE CURRENTLY WORKS AT A DENTAL OFFICE AND WAS GIVEN PALLIATIVE CARE INSTRUCTIONS BY A DENTIST IN HER OFFICE THAT CONSISTED OF WARM SALTWATER RINSES AND POSSIBLE GINGIVAL GRAFTING. THIS INCIDENT OCCURRED DUE TO USER ERROR, HOWEVER, THE PERMANENT DAMAGE THAT WAS CAUSED AND WILL NEED MEDICAL OR SURGICAL INTERVENTION TO RESTORE LEADS US TO REPORT THIS INCIDENT TO THE FDA.

  Patient problems: Caustic/Chemical Burns; Pain

  MAUDE report 18884012 ↗